Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
The study is an open label investigation of the cellular vaccine called 1650-G. Patients
receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will
be followed weekly after each vaccine injection and then monthly for 4 months. Patient
follow-up continues with evaluations at 6 months and 1 year after receiving the first
vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples
obtained at each visit following immunizations.
Inclusion Criteria:
- Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
- Surgically resected at least 4 weeks ago but not more than 6 months ago
- Bronchoalveolar carcinomas allowed
- Completion of any chemotherapy or radiation given in conjunction with Surgery
(neoadjuvant or adjuvant)
- No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan
within 6 weeks of enrollment
- ECOG performance status of 0 to 2
- Adequate organ and marrow function defined as follows:
- Hemoglobin ≥9.0 gm/dL
- Bilirubin < 2.5 x upper limit of normal
- AST <2.5 x upper limit of normal
- ALT <2.5 x upper limit of normal
- Creatinine <3 mg/dL
- Women of childbearing potential must have a negative pregnancy test and be willing to
use acceptable methods of contraception through week 16.
Exclusion Criteria:
- Cardiovascular disease defined as:
- New York Heart Association Class III or IV (Section 19.2) congestive heart
failure
- hemodynamically significant valvular heart disease
- myocardial infarction within the last six months
- active angina pectoris
- uncontrolled ventricular arrhythmias
- stroke within one year
- known cerebrovascular disease
- History of HIV, infectious hepatitis, or chronic immunosuppressive disease
- concurrent shorter courses of immunosuppressive medications during and for 16 weeks
after study treatment
- History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
- Female patients must not be pregnant or breastfeeding.
- History of participation in any investigational drug study within 4 weeks preceding
initiation of study treatment.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary Outcome Measure: Immunological Response; Antigen Specific Reactions Will be Measured by IFN-ELISPOT. The ELISPOT is a Quantitative Readout of Number of T Cells That React to Specific Antigenic Stimulus.
Outcome Description:
The endpoint is immunologic response measured by IFN-ELISPOT. Increases above pre-vaccine levels (& controls) can be assessed statistically by ANOVA. Percent patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine) as well as magnitude of responses (relative ELISPOT measures) will be compared to results obtained using DC/1650 vaccine. The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
Outcome Time Frame:
Evaluated for 52 weeks
Safety Issue:
No
Principal Investigator
Edward A Hirschowitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Kentucky
Authority:
United States: Food and Drug Administration
Study ID:
CTN-0505
NCT ID:
NCT00654030
Start Date:
October 2006
Completion Date:
November 2009
Related Keywords:
- Non-Small Cell Lung Cancer
- Lung Cancer Vaccine
- Early Stage Lung Cancer
- Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Louisville Hospital | Louisville, Kentucky 40202 |
| Owensboro Medical Health System | Owensboro, Kentucky 42303 |
| University of Kentucky | Lexington, Kentucky 40536-0098 |
| Commonwealth Cancer Center | Danville, Kentucky 40422 |
